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JAMA STUDY BY US FDA REPORTS RECORD-BREAKING 50-FOLD INCREASED RISK OF MYOCARDITIS, 10-FOLD INCREASED RISK IN 5-11, SAYS IT "ONLY" FINDS MYOCARDITIS AND PERICARDITIS IN CHILDREN AGED 15 TO 17 YEARS
They did not stratify the results by gender and dropped 75% of the records due to lack of medical records. RRs reported? 5.50, 3.95, 10.19, 3.47, 10.26, 22.44, 8.72, 3.49, 18.65, 4.98, 10.29, 50.01.
One of the authors of the study is from the US Food and Drug Administration.
From the article:
“Question Does active monitoring detect potentially elevated risk of health outcomes after BNT162b2 COVID-19 vaccination in the US pediatric population aged 5 to 17 years?
Findings In this cohort study of more than 3 million children (aged 5-17 years) who received BNT162b2 COVID-19 vaccination through mid-2022 using data from 3 US commercial claims databases, only myocarditis or pericarditis met the statistical threshold for a signal after BNT162b2 COVID-19 vaccination via near–real-time monitoring.
Meaning Results from near–real-time monitoring of health outcomes after BNT162b2 COVID-19 vaccination are consistent with current evidence and provide additional evidence of vaccine safety in the pediatric population.”
An epidemiologist asks the right questions:
She then also asks: “The rates appear to be based on 37 of 153 cases. Would there be signals for other events if cases were not discarded due to lack of medical records for review? Do we distrust the codes in these active surveillance databases that much? Or is this convenient to reduce the signal?”
Here’s some text from the study:
“Of the 153 cases of myocarditis or pericarditis among children aged 12 to 17 years, medical record review was conducted for a sample of 37 cases whose records were obtainable. Twenty-seven of these cases (73.0%) were confirmed as true cases of myocarditis or pericarditis, of which 25 patients were male, and 19 were hospitalized with a mean length of hospital stay of 2.8 days (median, 2 days). The mean time from vaccination to presentation for care for myocarditis or pericarditis was 6.8 days (median, 3 days).”
92% of confirmed cases were males. So she’s quite right. Where are the gender-stratified results?
The authors also wrote:
“We did not detect a signal for myocarditis or pericarditis in younger children (aged 5-11 years), which is consistent with reports from other surveillance systems.”
Close inspection shows that one of the high relative risk values, which for one database for one age group was a record-breaking RR = 50.01, was in fact elevated in 5-11 year-old vaccinees.
RR = 3.49 and 10.29???
They did not find these results?
I found it.
You can see it.
Dropping the 75% without medical records no doubt reduced the statistical power, the same trick used by the infamous Destefano et al study (2004) to make the association between on-time MMR vaccines and autism go away after rigorous p-hacking.
These are kids. Please retweet or share somewhere, wherever you hang out online.
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